Palatal expander with skeletal anchorage devices

ABSTRACT

A series of a palatal expanders increasing width can be used to gradually expand a patient&#39;s palate. Each palatal expander may have a palatal region flanked by teeth regions. The palatal region can have a plurality of anchor-receiving features (e.g., anchor interfaces) that allow the palatal expander to be attached to temporary anchorage device anchors that have been implanted into the patient&#39;s maxilla.

CLAIM OF PRIORITY

The application claims priority to U.S. Provisional Application No.62/517,404, filed Jun. 9, 2017, titled “PALATAL EXPANDER WITH TEMPORARYANCHORAGE DEVICES,” which is herein incorporated by reference in itsentirety for all purposes.

INCORPORATION BY REFERENCE

All publications and patent applications mentioned in this specificationare herein incorporated by reference to the same extent as if eachindividual publication or patent application was specifically andindividually indicated to be incorporated by reference.

FIELD

Embodiments of the invention relate generally to dental appliances, andmore specifically to dental appliances for expanding a patient's palate.

BACKGROUND

Palatal expanders are used to widen the palate of a patient's maxilla.Traditional palatal expanders typically have a metal frame that can beattached to the posterior teeth (molars and premolars) and an expansionscrew that can be activated to increase the width of the metal frame.The palatal expander exerts an outward force on the posterior teeth andtransmits this force to the surrounding bone in order to expand themaxilla and palate. However, the outward force on the posterior teethmay also cause an unwanted outward tipping of the posterior teeth whichserve as the anchors.

As an alternative to tooth-based anchorage, skeletal anchors, whichinclude dental implants and small implants, often referred to astemporary anchorage devices (TADs) can be implanted into the maxilla.Skeletal anchors are sometimes used to help move teeth by providing thedental practitioner additional anchorage locations for reciprocalorthodontic forces which move teeth to be generated on connected teeth.These skeletal anchors avoid the side effects of unwanted tooth movementtypically observed when anchor teeth are used instead. By reducing oravoiding side effects that need to be reversed by the clinician,treatment efficiency is increased, and efficacy may also be improved.

Designing a palatal expander that can widen the patient's maxilla andpalate with minimal or reduced unwanted movements to the patient's teethis therefore desirable.

SUMMARY OF THE DISCLOSURE

The present invention relates generally to dental appliances, and morespecifically to dental appliances for expanding a patient's palate thatinclude attachment sites for skeletal anchors (i.e, dental implantsand/or temporary anchorage devices (TADs)) in the patient's palate. Inparticular, described herein are palatal expanders having one or moreanchor interfaces (e.g., anchor-receiving, TAD receiving, etc.) portionsthat have an elastic interface therein, as well as methods of using themto expand a patient's palate and methods of forming them.

Any appropriate skeletal anchor may be used with the apparatuses andmethods described herein, including a dental implant or a TAD whichcomprises a screw, post, hook, protrusion, or the like. A dental implantis generally a structure that is attached to the patient's bone fordental restoration purposes, and can also be used for orthodonticanchorage purposes. A TAD is generally a structure that is attached tothe patient's bone for purposes of orthodontic anchorage andsubsequently removed after use. The TAD may include a head and a body.The head may protrude into the oral cavity slightly, and the body, whichmay be threaded, is implanted into the bone (e.g., palate). The head maybe shaped in a variety of configurations, including rounded, short,long, rectangular, etc. The head may contain features such as hooks andslots in order to accommodate the attachment of wires, springs, and orelastics. In general, the TAD may be biocompatible and sufficientlyrigid/strong to support the applied forces as described herein. Forexample, a TAD may be metallic (e.g., stainless steel, cobalt chromiumalloys, titanium, etc.), although the possibility of bioresorbableimplants manufactured from polylactides (polylactic acid, PLA),polyglycolides (polyglycolic acid, PGA) and their co-polymercompositions may also exist. The oral appliances described herein,including palatal expanders, may be configured to mate with the head ofthe TAD. As will be described in greater detail herein, any of theapparatuses described herein may include an anchor interface thatincludes an elastic interface. Alternatively or additionally, the TADmay include an elastic cover or overlay over all or part of the head sothat it is held between the TAD and the anchor interface of theapparatus.

Although the oral appliances for use with skeletal anchors describedherein are primarily palatal expanders, the methods and features(including, for example, elastic anchor-receiving interfaces) may beincorporated as part of any oral appliance for use with a bone anchor,including dental anchorage implants and the like.

An anchor interface generally includes a proximal opening in theapparatus, such as an opening into the oral appliance such as a palatalexpander (e.g., into and/or through the palatal region), in to which theanchor may be inserted. The opening may be adapted to help receive andcenter the anchor in the anchor interface. The anchor interface (e.g.,anchor-receiving portion) may also include a distal channel portion thatis continuous with the proximal opening. The anchor interface may passcompletely through the oral appliance such as the palatal expander, orit may just project into the apparatus, so that the bottom of the anchorinterface is closed. As will be described in greater detail here, thebody and/or the opening of the anchor interface may be adapted toinclude an elastic interface. The elastic interface may be a layer,coating, cover, sleeve, or the like on and/or within the anchorinterface which may be forced against the anchor when the apparatus isin use in the patient's oral cavity. In general, the elastic interfacemay be more compressible than the body of the apparatus in which theanchor interface is formed. For example, the body of the apparatus(e.g., palatal expander) may be somewhat rigid so that it may apply areaction force against the anchors and/or teeth to expand the user'spalate. The elastic interface within the anchor interface may thereforebe more elastic, and be more compressible than the body of theapparatus. The material of the elastic portion can be selected todeliver a specific amount of force generated per unit ofcompression/activation. The material of the elastic portion can also beselected to deliver a specific range or distance of activation within acertain force level. By including an elastic (or more compressible)region between the anchor and the anchor interface of the apparatus, theanchor may be more easily inserted into the apparatus and the apparatusmay be much more comfortably worn, without compromising the efficacy ofthe apparatus.

The anchor interface may have any cross-sectional profile, includinground, elliptical, polygonal (e.g., triangular, rectangular, square,pentagonal, hexagonal, heptagonal, octagonal, T-shaped, I-shaped, etc.).The cross-sectional profile may match the profile of the anchor thatextends from the patient's maxilla (including the head and/or shaft ofthe anchor). This may include attachments connected to the anchorportion embedded into the bone (e.g., an implant abutment connected to adental implant). The anchor interface may be straight or angled relativeto the plane of the adjacent palatal region. Each anchor interfacetypically engages with a single anchor extending from the patient'smaxilla.

For example, described herein are apparatuses (devices and/or systems)for expanding a patient's palate. Any of these apparatuses may beconfigured as a palatal expander, and may include: a palatal regionconfigured to be placed adjacent the patient's palate, wherein thepalatal region is sized and shaped to exert an outward, lateral forcethat expands the patient's palate, at least two anchor interfaceslocated on opposing lateral sides of the palatal region, the anchorinterfaces configured to receive anchors (e.g., TADs) implanted in thepatient's maxilla such that the outward, lateral forces exerted by thepalatal region are transmitted through the anchors to the patient'smaxilla. Any of these apparatuses may include an elastic interface onall or a part of each of the anchor interfaces. The elastic interfacemay have a greater elasticity than the palatal region such that ananchor will displace the elastic interface more than the palatal regionwhen the anchor is received in the anchor interfaces. As used herein thepalatal region may be configured to be adjacent to the patient's palatewithout touching it, so that a small gap or separation (e.g., 0.5 mm, 1mm, etc.) between the expander and the palate.

Any of the apparatuses described herein may also be configured as asystem or series of removable appliances, which can also includealigners. For example, described herein are systems for expanding apatient's palate that includes: a series of palatal expanders, whereineach palatal expander comprises: a palatal region configured to beplaced adjacent the patient's palate, wherein the palatal region issized and shaped to exert an outward, lateral force that expands thepatient's palate; at least two anchor interfaces configured to receiveanchors implanted in the patient's maxilla such that the outward,lateral forces exerted by the palatal region are transmitted through theanchors to the patient's maxilla. Each of the anchor interface may havean elastic interface therein, wherein the elastic interface has agreater elasticity than the palatal region such that an anchor willdisplace the elastic interface more than the palatal region when theanchor is received in the anchor interfaces. The two (or more) anchorinterfaces may be located on opposing lateral sides of the palatalregion.

As mentioned, in any of these apparatuses, the anchors may be temporaryanchorage devices (TADs). The palatal region may be based on a manual ordigital impression of the patient's palate. The anchors may also beimplant devices that are not temporary, such as those used forrestorative purposes.

Any of these apparatuses may include an anchor template having at leasttwo anchor guides for guiding implantation of the anchors into thepatient's maxilla, wherein the anchor guides are positioned on theanchor template such that the anchors are implanted into the patient'smaxilla in locations that correspond to the anchor interfaces of atleast one of the palatal expanders (e.g., the first palatal expander ina series) when the palatal expander is worn by the patient.

In any of the apparatuses described herein, the anchor interfaces mayhave a sloped surface configured to facilitate insertion of the anchorsinto the anchor interfaces. This sloped surface may be on the proximalopening of the anchor interface. The sloped surface may extend aroundthe entire perimeter of the anchor interface opening, or it may extendonly partially around the outer perimeter of the anchor interface, andparticularly around the face that is closest to the midline of theapparatus, which may align with the midline of the palate when worn.

As mentioned, the elastic interface may comprise a compressiblematerial. This compressible material may be a polymeric material. Thecompressible material may be a rubber, silicone, or other material. Theelastic interface may be lubricious, and/or a separate lubriciouscoating may be included. For example, the proximal opening of the anchorinterface may be lubricious in addition to being sloped.

In any of the methods and apparatuses described herein, the compressiblematerial may be a spring or clip (e.g., metal clip) that may act as aforce generator instead of, or in addition to, an elastic material. Forexample, a clip may be used as a spring, wherein the clip may bestainless steel, or nickel titanium alloy, or copper nickel titaniumalloy, which may have a more consistent (flat) force to deflectioncurve.

The thickness of the compressible material may be between about 0.1 mmto 2.0 mm. (e.g., between 0.2 mm and 1.5 mm, between 0.2 mm and 1.3 mm,between 0.2 mm and 1.2 mm, between 0.2 mm and 1.0 mm, between 0.2 mm and0.9 mm, etc.).

Each apparatus (e.g., palatal expander) may include two or more anchorinterfaces. For example, each apparatus may include at least threeanchor interfaces, at least four anchor interfaces, etc.

The palatal region of the apparatus may generally be configured to beplaced against the patient's palate when the anchors are inserted intothe anchor interfaces.

At least a portion of the palatal region may be configured to be spacedapart from the patient's palate when the anchors are inserted into theanchor interfaces. The palatal expanders described herein may befabricated from a rigid or semi-elastic material. Any of the apparatusesdescribed herein may be configured as a palatal expander comprising ateeth region configured to be placed over a portion of the patient'steeth. The teeth region may be configured to be placed over the lingualsurfaces of the patient's teeth. Alternatively or additionally, theteeth region may be configured to be placed over the occlusal surfacesof the patient's teeth. Alternatively or additionally, the teeth regionmay be configured to be placed over the buccal surfaces of the patient'steeth.

A palatal expander for expanding a patient's palate may include: apalatal region configured to be placed adjacent the patient's palate,wherein the palatal region is sized and shaped to exert an outward,lateral force to expand the patient's palate by a predetermined amount;at least two anchor interfaces located on the palatal region; andwherein each of the anchor interfaces has an elastic interface therein,wherein the elastic interface has a greater elasticity than the palatalregion and is configured to compress at least about 10 percent (e.g., 10percent or more, 20 percent or more 25 percent or more, 30 percent ormore, 40 percent or more 50 percent or more, etc.) of the predeterminedamount.

Also described herein are methods of using any of the apparatusesdescribed herein. For example, described herein are methods of using theapparatuses described herein to expand a patient's palate. These methodsmay include: placing a palatal expander adjacent the patient's palate,wherein the palatal expander comprises a body and at least two anchorinterfaces in the body; inserting a pair of anchors (which may belocated on opposing lateral sides of the patient's palate) embedded inthe patient's palate into the at least two anchor interfaces of thepalatal expander; and compressing an elastic interface within each ofthe anchor interfaces more than the body, such that the implantedanchors are inserted into the anchor interfaces of the palatal expander.Any of these methods may also include obtaining a palatal expandermodeled on the patient's palate.

Any of these methods may also include removing the palatal expanderafter a period of time has elapsed and inserting placing a secondpalatal expander adjacent to the patient's palate and inserting the pairof anchors into at least two anchor interfaces of the second palatalexpander. The second palatal expander may be wider than the firstpalatal expander.

Also described herein are methods of forming a series of palatalexpanders for expanding a patient's palate, the method comprising:obtaining a manual or digital impression of the patient's palate;fabricating a series of palatal expanders based on the impression of thepatient's palate, wherein each palatal expander comprises a body and atleast two anchor interfaces formed in the body; and positioning anelastic interface within at least two anchor interfaces, wherein theelastic interface has material compliance that is greater than amaterial compliance of the body of the palatal expander.

Also described herein are systems. For example, a system may beconfigured as a system for expanding a patient's palate through aplurality of incremental stages of palatal expansion. The system mayinclude: a plurality of palatal expanders, each palatal expander of theplurality of palatal expanders configured to expand the patient's palatecomprising: a palatal region configured to mate with the patient'spalate at one incremental stage of the plurality of incremental stagesof palatal expansion, and to exert an outward, lateral force on thepatient's palate during the one incremental stage of palatal expansion;and at least two anchor interfaces, each anchor interface configured toreceive an anchor extending from a maxilla of the patient therein, andto direct at least a portion of the outward, lateral force to themaxilla through the anchors to facilitate skeletal expansion of themaxilla during the one incremental stage of palatal expansion.

In some implementations, each of the at least two anchor interfaces ofthe palatal expanders of each of the plurality of palatal expanders hasan elastic interface therein, wherein the elastic interface has agreater elasticity than the palatal region such that an anchor willdisplace the elastic interface more than the palatal region when theanchor is received in the anchor interfaces. In some implementations,the elastic interface comprises a compressible material. Thecompressible material may have an uncompressed thickness of betweenabout 0.2 mm to 1.5 mm.

In some implementations, the palatal region of the each of the palatalexpanders has a first rigidity; and the each palatal expander of theplurality of palatal expanders has a soft portion having a secondrigidity less than the first rigidity, the second rigidity configured togrip (e.g., facilitate a gripping force) and couple the plurality ofanchors to the each palatal expander of the plurality of palatalexpanders.

In some implementations, the at least two anchor interfaces are locatedon opposing lateral sides of the palatal region. The plurality ofanchors may be a plurality of temporary anchorage devices. The at leasttwo anchor interfaces of the each palatal expander of the plurality ofpalatal expanders may be integrally formed with the each palatalexpander of the plurality of palatal expanders.

In some implementations, the at least two anchor interfaces of eachpalatal expander of the plurality of palatal expanders are directlyfabricated with each palatal expander of the plurality of palatalexpanders. In some implementations, an anchor template may have at leasttwo anchor guides for guiding implantation of the plurality of anchorsinto the maxilla, wherein the at least two anchor guides are positionedon the anchor template such that the plurality of anchors are insertedinto the maxilla in anchor locations that correspond to the anchorinterfaces of each palatal expander of the plurality of palatalexpanders.

In some implementations, the plurality of anchor interfaces have asloped surface configured to facilitate insertion of the at least twoanchors into the plurality of anchor interfaces. Each palatal expanderof the plurality of palatal expanders may comprise at least four anchorinterfaces. The palatal region may be configured to be placed againstthe patient's palate when the at least two anchors are inserted into theplurality of anchor interfaces.

In some implementations, at least a portion of the palatal region isconfigured to be spaced apart from the patient's palate when the anchorsare inserted into the anchor interfaces. The plurality of palatalexpanders may be fabricated from a rigid or semi-elastic material. Eachpalatal expander of the plurality of palatal expanders may comprise ateeth region configured to be placed over a portion of the patient'steeth. In some implementations, the teeth region is configured to beplaced over one or more of the lingual surfaces of the patient's teeth,the occlusal surfaces of the patient's teeth, and the buccal surfaces ofthe patient's teeth.

A system for expanding a patient's palate may comprise: a series ofpalatal expanders, wherein each palatal expander comprises: a palatalregion, wherein the palatal region is sized and shaped to exert anoutward, lateral force that expands the patient's palate; at least twoanchor interfaces located on opposing lateral sides of the palatalregion, the anchor interfaces configured to receive anchors implanted inthe patient's maxilla such that the outward, lateral forces exerted bythe palatal region are transmitted through the anchors to the patient'smaxilla; and wherein each of the anchor interfaces has an elasticinterface therein, wherein the elastic interface has a greaterelasticity than the palatal region such that an anchor will displace theelastic interface more than the palatal region when the anchor isreceived in the anchor interfaces.

In some variations, a system (including a system for expanding apatient's palate through a plurality of incremental stages of palatalexpansion) may comprise: a plurality of incremental palatal expanders,each palatal expander of the plurality of palatal expanders comprising:a palatal region configured to mate with a palate of a patient at one ofthe plurality of incremental stages of palatal expansion, and to exertan outward, lateral force on the palate during the one incremental stageof palatal expansion; and means for receiving a plurality of anchorsinserted in a maxilla of the patient, and when the plurality of anchorsare received, for directing at least a portion of the outward, lateralforces to the maxilla through the plurality of anchors, therebyfacilitating skeletal expansion of the maxilla during the oneincremental stage of palatal expansion.

A method for expanding a patient's palate may comprise: placing apalatal expander adjacent the patient's palate, wherein the palatalexpander comprises a body and at least two anchor interfaces in thebody; inserting a pair of anchors embedded in the patient's palate intothe at least two anchor interfaces of the palatal expander; andcompressing an elastic interface within each of the anchor interfacesmore than the body, such that the implanted anchors are inserted intothe anchor interfaces of the palatal expander.

A method for expanding a patient's palate may comprise: placing apalatal expander adjacent the patient's palate, wherein the palatalexpander comprises a body and at least two anchor interfaces in thebody; inserting at least one anchor of the at least two anchorinterfaces of the palatal expander embedded into the patient's maxilla;and compressing an elastic interface within each of the anchorinterfaces more than the body, such that the implanted anchors areinserted into the anchor interfaces of the palatal expander. In someembodiments, the implant placed into the patient's maxilla can be aregular dental implant, while the implant placed in the palate may be aTAD or regular implant. In some embodiments, the implants are placed inthe maxillary ridge. In some embodiments, two implants can be placed onopposing sides of the maxilla/maxillary ridge.

In some implementations, the pair of anchors are embedded on opposinglateral sides of the patient's palate. The method may further compriseremoving the palatal expander after a period of time has elapsed andinserting placing a second palatal expander adjacent to the patient'spalate and inserting the pair of anchors into at least two anchorinterfaces of the second palatal expander. In some implementations, thesecond palatal expander is wider than the first palatal expander.

A method for palatal expansion may comprise: gathering a palatalexpander, the palatal expander comprising: a palatal region configuredto mate with a palate of a patient at an incremental stage of palatalexpansion; and a plurality of anchor interfaces configured to receive aplurality of anchors configured to be inserted in a maxilla of apatient; coupling the palatal region to the palate of the patient toexert an outward, lateral force on the palate during the incrementalstage of the palatal expansion; and coupling the plurality of anchorinterfaces to the plurality of anchors to direct at least a portion ofthe outward, lateral force to the maxilla through the plurality ofanchors, thereby facilitating skeletal expansion of the maxilla duringthe incremental stage of palatal expansion.

In some implementations, the method may include inserting the pluralityof anchors into the maxilla through a plurality of openingscorresponding to the plurality of anchor interfaces. In someimplementations, the incremental stage is a first stage, an intermediatestage, or a final stage of the palatal expansion.

A computer-implemented method of forming a plurality of incrementalpalatal expanders may comprise: gathering a plurality of representationsof a palate of a patient at a plurality of stages of palatal expansionin accordance with a palatal expansion plan; identifying in each of theplurality of representations of the palate a stage-specific plurality ofanchor locations for the corresponding stage of palatal expansion, thestage-specific plurality of anchor locations being associated withlocations of a plurality of anchors to be inserted into a maxilla of thepatient at the corresponding stage of palatal expansion; virtuallyrepresenting a plurality of incremental palatal expanders for theplurality of stages of palatal expansion, each of the plurality ofincremental palatal expanders having a palatal region and a plurality ofstage-specific anchor interfaces at the stage-specific plurality ofanchor locations, the stage-specific anchor interfaces configured toreceive the plurality of anchors; and providing instructions tofabricate the plurality of incremental palatal expanders for theplurality of stages of palatal expansion using the plurality of virtualrepresentations of the plurality of incremental palatal expanders.

In some implementations, the plurality of stage-specific anchorinterfaces are configured to direct at least a portion of the outward,lateral force to the maxilla through the plurality of anchors. Theinstructions to fabricate may comprise instructions to directlyfabricate the plurality of incremental palatal expanders. Thestage-specific plurality of anchor locations may comprise one or morepairs of anchor locations, the anchor locations in each pair having asubstantially equidistant distance from a midline of the palate.

In some implementations, the substantially equidistant distance of theeach pair of anchor locations at an earlier stage of palatal expansionof the plurality of stages of palatal expansion is smaller than thesubstantially equidistant distance of the each pair of anchor locationsat a later stage of palatal expansion of the plurality of stages ofpalatal expansion.

In some implementations, the palatal region of the each palatal expanderof the plurality of palatal expanders has a first rigidity; and the eachpalatal expander of the plurality of palatal expanders has a softportion having a second rigidity less than the first rigidity, thesecond rigidity configured to facilitate a gripping force to couple theplurality of anchors to the each palatal expander of the plurality ofpalatal expanders.

In some implementations, the soft portion resides inside at least aportion of the plurality of stage-specific anchor interfaces. The softportion may reside inside a portion of the palatal region.

A method of forming a series of palatal expanders for expanding apatient's palate may comprise: obtaining a manual or digital impressionof the patient's palate; fabricating a series of palatal expanders basedon the impression of the patient's palate, wherein each palatal expandercomprises a body and at least two anchor interfaces formed in the body;and positioning an elastic interface within at least two anchorinterfaces, wherein the elastic interface has material compliance thatis greater than a material compliance of the body of the palatalexpander.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features of the invention are set forth with particularity inthe claims that follow. A better understanding of the features andadvantages of the present invention will be obtained by reference to thefollowing detailed description that sets forth illustrative embodiments,in which the principles of the invention are utilized, and theaccompanying drawings of which:

FIG. 1A illustrates a palatal expander as described herein.

FIG. 1B illustrates a cross-sectional view of a palatal expander thathas been placed against the palate.

FIG. 1C illustrates a close-up view of temporary anchorage device anchorinserted into an anchor interface of the palatal expander.

FIG. 1D illustrates various orientations of the implanted temporaryanchorage device anchor in the maxilla.

FIG. 1E illustrates an embodiment of a series of palatal expanders forprogressively expanding a patient's palate as described herein.

FIG. 2 illustrates the differences in the force curves for a palatalexpander made of a rigid material and a palatal expander incorporating aflexible, elastic, and/or compressible material.

FIGS. 3A and 3B illustrate various embodiments of palatal expanders asdescribed herein.

FIGS. 4A and 4B illustrate sectional views through examples ofinterfaces for temporary anchorage devices (TADs) as the anchor pointsin a palatal expander. FIG. 4A shows a TAD interface portion comprisingan opening into the body of the palatal expander having a beveled (e.g.,ramped) edge on the inward-facing side of the opening. FIG. 4B shows anexample of a TAD interface portion of a palatal expander having abeveled edge around the entire opening; in this example the TADinterface includes a more compliant surface (e.g., an elastic material)lining at least a part of the opening and TAD interface portion.

FIGS. 4C-4H illustrate examples of sections through an interface fortemporary anchorage devices (TADs) as the anchor points in a palatalexpander. In FIG. 4C, the interface forms an opening through the body ofthe palatal expander; the opening region into the interface is beveledor ramped (alternatively just one portion, such as the side facing themidline of the palatal expander, may be ramped or beveled). FIG. 4Dshows an interface for a TAD in which the inner wall comprises acompliant material (e.g., a material having a highercompliance/elasticity than the body of the palatal expander. This regionof complaint material may be a coating or layer and/or may cover theentire interface, including the proximal opening region and/or the moredistal inner channel region, or just a portion of the interface. Forexample, FIG. 4E shows a variation in which only the proximal openingregion (shown here as a ramped or beveled region) includes a compliantmaterial. In FIG. 4F, only the portion of the interface, such as theportion that is nearest to the midline of the palatal expander body,which will apply force against the anchor, includes the more compliantsurface(s). In FIG. 4G the more distal inner channel region includes amore compliant surface (but not the proximal opening region, shown hereas ramped). In FIG. 4H, only a portion of the distal inner channelregion includes a more compliant surface, such as the portion that isnearest to the midline of the palatal expander body, which will applyforce against the anchor.

FIG. 5 illustrates one method of expanding a patient's palate using anyof the apparatuses described herein including an elastic interfacewithin an anchor interface in the apparatus.

FIG. 6 illustrates one method of forming an apparatus including ananchor interface having an elastic interface, as described herein.

FIG. 7 is a flow chart that illustrates a computer implemented methodfor fabricating a dental appliance.

FIG. 8 is a flow chart that illustrates an example of acomputer-implemented method for designing and/or fabricating a pluralityof incremental palatal expanders.

DETAILED DESCRIPTION

Described herein are oral apparatuses that may be used with a skeletalanchorage device that is attached in a patient's bone, such as thepatient's palate. Any of these apparatuses may include an anchorinterface that includes or is adapted for use with an elastic interface,which may be an interface surface, sleeve, coating, layer, etc., that isinterposed between the anchor interface (e.g., anchor-receiving portion)and an anchor (e.g. temporary anchorage device (TAD), dental implant)inserted into the anchor interfaces. The elastic interface may beconfigured to compress when the apparatus applies force against theanchor to move the palate and/or teeth. Also described hereinapparatuses and methods of using and making them that are adapted topermit easier removal and secure application of an anchor in an anchorinterface.

A TAD may be substantially smaller than a typical dental implant. Insome embodiments, the TAD has a length of less than about 10 mm and adiameter of less than about 2 mm. In some embodiments, the TAD has alength of between about 3 and about 12 mm (e.g., has a length of about5, 6, 7, 8, 9, or 10 mm) and a diameter of between about 0.9 and 2.1 mm(e.g., about 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, and 2.0mm). In contrast, regular dental implants are typically over 10 mm inlength and 3-5 mm in diameter. Because the TAD is much smaller than atraditional screw type implant, the placement procedure is lesscomplicated, loading can be more immediate, and the patient recoverytime is quicker.

In particular, the anchors may be configured to support a palatalexpander. Palatal expanders can be used with anchors that allow thepalatal expander to apply the expansion load directly to the patient'sbone, (e.g., the maxilla), instead of to the posterior teeth. Thepalatal expander can have sockets, receptacles, or some other receivingfeatures that can couple with and/or receive one end of a bone anchor(e.g., TAD or implant).

In one embodiment as shown in FIGS. 1A-1E, a series of incrementalpalatal expanders 100 can be used to gradually expand and widen thepatient's maxilla 108 and palate, typically by causing separation and/orexpansion of the suture 109 of the maxilla 108. Only one palatalexpander 100 is shown in FIG. 1A, but the other palatal expanders 100′,100″, 100′″ share a similar shape, with the primary difference being thewidth of the palatal region 102 as shown in FIG. 1E. Each palatalexpander 100 can have a palatal region 102 shaped and sized to be placedagainst or adjacent to a portion of the patient's palate, such as theposterior portion of the patient's palate. The palatal expander 100 mayalso have one or more teeth receiving portions 104 surrounding thepalatal region 102. The teeth receiving portion 104 may be sized andshaped to receive or fit against the lingual surfaces of the teeth, andoptionally against the occlusive and lingual surfaces. The width of thepalatal region 102 can be oversized relative to the width of thepatient's palate so that when the palatal expander is worn, it exerts anoutward, lateral force that expands the patient's palate. In someembodiments, the lateral expansionary force can be between about 5 to 50Newtons. The width of the palatal region can increase with eachsuccessive palatal expander in the series.

The shape and size of the palatal region 102 may be based on an analog(e.g., alginate or polyvinyl silicone dental material) or digitalimpression of the patient's palate. In some embodiments, the palatalregion 102 is designed to contact the palate, while in otherembodiments, the palatal region 102 is offset a set or predetermineddistance from portions of the palate. A refractory model of the palateand the upper teeth can be formed from the analog or digital impression,and a polymer material can be used to fabricate the palatal expanderusing the model. Alternatively, the palatal expander can be formed usingdirect fabrication processes, such as 3-D printing for example, based onthe digital set-up of the palate and teeth. The material used tofabricate the body of the palatal expander may be rigid, semi-rigid, orsemi-elastic. Use of a semi-rigid or semi-elastic material can providethe palatal expander with a degree of flexibility that can lower theforce delivered to the maxilla.

In a traditional palatal expander, much of the lateral force is appliedto the patient's posterior teeth, typically the distal molars. In orderto offload at least some of the force from the patient's teeth, anchors106 can be implanted into the patient's maxilla 108 as shown in FIG. 1B.At least one anchor 106 can be inserted into each lateral side of themaxilla 108. Additional anchors, such as two, three, or four or moreanchors can be implanted in each side in order to disperse the outwardforce more evenly over a larger portion of the maxilla. The anchors 106can be implanted into the maxilla 108 in various orientations andconfigurations. For example, as shown in FIG. 1D, the anchors 106 a canbe implanted to be oriented in a superior to inferior orientation, orthe anchors 106 b can be implanted normal to the bone surface, or theanchors 106 c can be implanted in a medial to lateral orientation inalignment with the direction of the outward expansionary force. In someembodiments, the anchors can be inserted in an intermediate orientationbetween the medial to lateral orientation and the normal orientation orbetween the normal orientation and the superior to inferior orientation.The portion of the anchor that extends out of the palate can terminatein a head with a socket that can be used to drive the into the palate.The socket can have a variety of shapes, such as rectangular, key, star,hex, slot, cross, and the like. A screwdriver with a complementaryshaped head can be used to drive the anchor into the palate.

To secure the palatal expander 100 to the anchors 106, as shown in FIGS.1A-1C, the palatal region 102 can have anchor interfaces 110 located onopposing lateral sides of the palatal region 102 and/or the maxillaryregion 103. The anchor interfaces 110 can be sockets, receptacles,cavities, recesses, buckets, holes, or other receiving features that areconfigured to removably receive the portion of the implanted anchors 106that extend out of the patient's palate after implantation. When theimplanted anchors 106 are seated in the anchor interface 110, theoutward, lateral forces exerted by the palatal region 102 aretransmitted through the anchors 106 to the patient's maxilla 108.

In some embodiments, each of the anchor interfaces 110 may have a liner112. The liner 112 may be made of a flexible, elastic and/orcompressible material to form a flexible, elastic and/or compressibleinterface within the anchor interface 110. The liner 112 may have agreater flexibility, elasticity and/or compressibility than the palatalregion 102 such that the anchor 106 will displace the liner 112 morethan the palatal region 102 when the anchor 106 is received in theanchor interface 110. The liner 112 can be provided as a coating orinsert. For example, the liner 112 can be an O-ring insert, a tube-likeinsert or a cup-like insert. In some embodiments, the liner 112 can be3-D printed or otherwise fabricated or integrated into the anchorinterfaces 110 rather than being an insert. The combination of the liner112 with the receptacle can form a connection plug that can be snappedover the end of the anchor. As shown in FIG. 1C, the anchor interfaces110 can also have a sloped surface 114 and/or curved surface at theopening to facilitate insertion of the anchors 106 into the anchorinterfaces 110. In addition, the head of the anchor can be tapered toalso facilitate insertion into the anchor interfaces 110. The anchorinterfaces 110 can extend through the full thickness of the palatalregion 102 or partially through the thickness of the palatal region 102.

As shown in FIG. 2, the use of the flexible, elastic and/or compressibleliner 112 allows the palatal expander 100 to apply a more constant levelof force over a larger range of strain or deformation of the palatalexpander 100 over a completely rigid device, thereby allowing thepalatal expander 100 to reduce the peak force applied to the palate,maxilla, and or teeth and more comfortably expand the maxilla by a setand/or predetermined amount, such as about 0.1 to 2.0 mm/day ofexpansion, or about 0.2 to 1.0 mm/day of expansion, or about 0.2 to 0.5mm/day of expansion. The elasticity and compliance of the liner can beadjusted to modulate the force applied to the anchors. Increasing theelasticity or compliance results in less force applied to the anchors,and decreasing the elasticity or compliance results in more forceapplied to the anchors. To accommodate the desired amount of expansion,the thickness of the liner 112 can be based on the amount of the desiredamount of expansion, such as the thickness being about half the desiredamount expansion plus an optional amount of buffer, such as about 0.2 to0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8,1.9 or 2.0 mm. The flexible, elastic and/or compressible liner 112 alsomakes it easier to insert the anchor into the anchor interfaces 110 andalso improve the grip of the anchor interface 110 to the anchor. In someembodiments, the anchors can be made of a semi-elastic material insteadof or in addition to the palatal expander.

To determine the implantation sites for the anchors in the patient'spalate and to match the locations of the anchor interfaces 110 of thepalatal expander 100 to the implantation sites, a template can be used.The template can be formed from a manual or digital impression of thepatient's palate and teeth and can be sized and shaped similarly to theincremental palatal expanders. However, instead of having anchorinterfaces, the template can have a plurality of anchor guides, whichcan simply be holes in the template, for guiding implantation of theanchors into the patient's palate and maxilla. The anchor guidelocations can be customized to the patient to optimize the locations ofthe anchors in the maxilla. Once the anchor guide locations aredetermined on the template, the anchor interfaces 110 of the incrementalpalatal expanders 100 can be positioned to correspond to the anchorlocations and orientation in the patient's maxilla and palate.

Alternatively, in some embodiments, the anchors are first inserted intothe palate, and then an impression of the palate with embedded anchorsis taken. This impression will have the location of the anchors and canbe used to design and fabricate the palatal expander.

FIG. 3A illustrates an alternative embodiment of a palatal expander thatis similar to the palatal expander shown in FIGS. 1A-1C. The palatalexpander 300 can have a palatal region 302 that is flanked by teethregions 304. A plurality of anchor interfaces 306 can be positioned onboth sides of the palatal region 302. However, in this embodiment, thepalatal region 302 can include a split 308 that divides the palatalregion 302 into two halves. Sliding features 310 and a screw typeexpansion mechanism 312 can be included to allow the palatal region 302to be expanded by turning the screw. Because this palatal expander 300can be expanded, it may partially or completely replace the series ofpalatal expanders. In addition, the palatal expander 300 can beoptionally provided with one or more spring features that can provideadditional control over the amount of force applied to the maxilla andpalate. The spring features can be embedded in the palatal region and/orincorporated into the expansion mechanism.

FIG. 3B illustrates another embodiment of a palatal expander that issimilar to the palatal expander shown in FIG. 3A. In this embodiment,the palatal expander 300′ can include a full aligner 304′ that coversall the teeth in the upper jaw and a palatal region 302′ that covers thepalate. Using a full aligner that covers all the teeth allows control ofthe movement of all the teeth during the procedure to expand the palate.For example, this may allow the increased spacing between the teeth tobe distributed more evenly between the teeth instead of beingconcentrated between the teeth straddling the midline of the palate. Aplurality of anchor interfaces 306′ can be positioned on both sides ofthe palatal region 302′. The palatal region 302′ can include a split308′ that divides the palatal region 302′ into two halves. Slidingfeatures 310′ and a screw type expansion mechanism 312′ can be includedto allow the palatal region 302′ to be expanded by turning the screw.Because this palatal expander 300′ can be expanded, it may partially orcompletely replace the series of palatal expanders. In addition, thepalatal expander 300′ can be optionally provided with one or more springfeatures that can provide additional control over the amount of forceapplied to the maxilla and palate. The spring features can be embeddedin the palatal region and/or incorporated into the expansion mechanism.

The teeth receiving portions of both the full aligner and the partialaligner embodiments of the palatal expander can be used to progressivelymove teeth. In addition, the anchors can also be used as resistancepoints to help control the tooth movement, including generating upwardsor downwards resistance force, for example, to allow extrusion orintrusion of the teeth.

The procedure for expanding the patient's palate can begin withobtaining a manual or digital impression of the patient's palate. Theimplantation sites for the anchors can be determined based on thepatient's anatomy and the desired dispersal of forces to the maxilla.For example, at least one anchor site can be chosen for each side of themaxilla. Using additional anchors improves the stability of the systemand reduces the risk of failure that may be cause by focusing too muchforce onto a particular anchor. Therefore, in some embodiments, at leasttwo, three, or four anchor sites are chosen for each side of themaxilla. A series of palatal expanders and an anchor template can befabricated based on the impression of the patient's palate.

The anchors can be implanted into opposing lateral sides of thepatient's palate and maxilla using the anchor template. The anchorinterfaces of the series palatal expanders and the anchor guides of theanchor template are in alignment so that the palatal expanders can beplaced over and secured to the anchors.

A first palatal expander from the series of palatal expanders can beplaced adjacent the patient's palate and optionally, over at least someof the patient's teeth, such as the posterior teeth (molars andpremolars). The anchors can be inserted into the anchor interfaces ofthe palatal expander. The anchors may compress an elastic interfacewithin the anchor interfaces more than the palatal region is compressedor deformed. After a period of time has elapsed, the first palatalexpander can be removed and replaced by the next incremental palatalexpander from the series, where the next incremental palatal expander iswider than the first palatal expander. The period of time betweenreplacements can be at least one, two, three, four, five, six, or sevendays. Larger and larger palatal expanders are inserted until the desiredamount of palatal expansion is achieved.

If an expandable palatal expander is used as illustrated in FIGS. 3A and3B for example, the screw type expansion mechanism can be rotatedperiodically, such as every 1, 2, 3, 4, 5, 6, or 7 days, according to aprescribed schedule. If the expandable palatal expander reaches itsmaximum diameter before the desired expansion of the palate has beenachieved, it can be replaced with a larger version.

In some embodiments, the palatal expander can include one or more shapememory alloy expansion elements that function to expand the device whenheated to body temperature. For example, a shape memory alloy ribbon orwire can have a collapsed configuration (i.e., an “S” configuration)below body temperature and an expanded configuration (i.e. astraightened configuration) at body temperature. In some embodiments,this expansion element can be used to join the two halves of theexpandable palatal expander together, and as the expansion element isheated, it can push the two halves apart.

FIGS. 4A-4H illustrate examples of anchor interfaces that may be usedwith any of the apparatuses described herein, including the palatalexpanders such as those shown in FIGS. 1A and 3. These figures show asimplified or schematic cross-section through an anchor interfaces or anexemplary apparatus such as a palatal expander. In FIG. 4A, the anchorinterfaces is part of a palatal expander 402 and includes a distalopening 401 continuous with a proximal channel 403. An anchor 406 may beinserted into the anchor interface. In FIG. 4A, the anchor interfacesincludes a sloped or beveled proximal opening 407, as discussed above.In this example, the circumferentially opposite side 409 of the openingis less sloped. For example, in a palatal expander, the side of theproximal opening into the anchor interface closes to the midline of theapparatus may include a ramp or slope (or more of a ramp or slope)compared to the opposite side, since the palatal expander may generallyhave an initially greater diameter than the patient's palate andinserting the anchor into the anchor interface may require force to bendor collapse the palatal expander slightly so that it will fit into thearch of the mouth, as described above.

In some embodiments, the palatal expander can be heated prior toinsertion into the patient's mouth to make the palatal expander morepliable and flexible. This makes it easier to bend and manipulate thepalatal expander when inserting the anchors into the anchor receivingportions. In some embodiments, the palatal expander can be heated tobetween 25 degrees C. and 43 degrees C. (e.g., heated to up to 37, 38,39, 40, 41, or 42 degrees Celsius).

FIG. 4B shows an example of an anchor interface of a palatal expander inwhich an elastic interface 404 is included. This this example, theelastic interface is on a wall of the anchor interface, including boththe proximal opening region as well as the distal channel. As will bedescribed in greater detail below, the elastic interface may extend toonly a portion of the anchor interface (e.g., only in the proximalopening, only in the distal channel portion of the anchor interface,etc.) and/or only partially around the anchor interface (e.g., againstthe side of the anchor interface that is closest to the midline of thedevice, the midline of the patient holding the apparatus.

In the apparatuses shown in FIGS. 4A and 4B, the anchor interfaces donot extend completely through the apparatus. Alternatively, as shown inFIGS. 4C to 4H, the anchor interface may extend completely through thebody of the apparatus (e.g., expander). In FIG. 4C, similar to thatshown in FIG. 4A, the proximal opening is sloped. In this example, theproximal opening is sloped around its entire circumference, although itmay only be sloped on the side against which the anchor will be pushedwhen the apparatus is worn (e.g., in most instances, the side closest tothe midline of the apparatus). FIG. 4D is similar to the variationsshown in FIG. 4C, but also passes completely through the apparatus. FIG.4E shows a variation in which the elastic interface is located on justthe region forming the ramped proximal opening. In FIG. 4F, the elasticinterface is positioned just on one side (only partiallycircumferentially around) the anchor interface. This side 408 may be theside from which the majority of force, e.g., expansion force, is appliedto the anchor. The elastic interface may be preferentially located tointerpose between the anchor and the anchor interface when the apparatusis worn. Similarly, FIG. 4G shows a variation in which the distalchannel portion of the anchor interface, which is also open at thebottom of the apparatus, includes an elastic interface. Finally, FIG. 4Hshows an example in which just the side of the distal channel portionfacing the midline, which will push against the anchor when expandingthe patient's palate, includes an elastic interface.

Any of the apparatuses described herein may be used to expand a palate.These methods of use may further illustrate the advantages of theseapparatuses, including For example, FIG. 5 schematically illustrates onemethod of expanding a patient's palate. In this example, the personinserting the apparatus, which may be a medical/dental professional(doctor, technician, orthodontist, etc.) may first obtain a palatalexpander (e.g., a first palatal expander) that is modeled on thepatient's palate or palate and teeth 501. Thereafter, the palatalexpander may be placed adjacent the patient's palate 503. This may beachieved by inserting it into the subject's mouth. Once inserted intothe mouth, the apparatus may be secured by inserting a pair of anchors(e.g., implants or Temporary Anchoring Devices (TADs)) on the patient'spalate into anchor interfaces (interfaces) of the palatal expander. Thisstep may include laterally compressing the palatal expander to align theanchors with the anchor interfaces 507. This step may also includesliding the anchor along a ramp at the proximal opening of the anchorinterface and into the channel of the anchor interface 509.

Any of these methods may also include compressing an elastic interfacewithin the anchor interfaces (more than the body of the palatalexpander) such that the implanted anchors are inserted into the anchorinterfaces of the palatal expander 511.

Finally, also described herein are method of forming or fabricating anapparatus including an anchor interface as described. For example, FIG.6 provides a schematic overview of a method for forming an apparatusincluding an anchor interfaces and an elastic interface within theanchor interfaces. For example, a method of forming a series of palatalexpanders for expanding a patient's palate may include: obtaining amanual or digital impression of the patient's palate 601; fabricating aseries of palatal expanders based on the impression of the patient'spalate, wherein each palatal expander comprises a body and at least twoanchor interfaces formed in the body 603; and including an elasticinterface within at least two anchor interfaces, wherein the elasticinterface has material compliance that is greater than a materialcompliance of the body of the palatal expander 605. The elasticinterface may be formed with the fabrication of the palatal expander,and/or added (e.g., as a coating, insert, etc.) after the rest of thepalatal expander has been formed.

Device Fabrication

The design and fabrication process of the custom features specific foreach patient provides dynamic flexibility to change the featurelocations, sizes and shapes at specified stages in the treatment. Forexample, the process allows (1) shifting/moving the anchorage locationduring treatment to reduce the time that soft tissue is in contact withthe aligner/palatal expander to minimize irritation; and/or (2) changingthe anchorage location, shape and/or size to adjust (in terms of forceor pressure) to changes in the arch during treatment. Suitablefabrication processes include additive manufacturing process, one piecethermoform, one piece direct print fabrication, two piece snap-in lock,two piece sonic weld, and two piece adhesive bond.

FIG. 7 is a flow chart that illustrates a computer implemented methodfor fabricating a dental appliance. The method can be implemented on acomputer having a processor, memory, and software that is programmed toimplement the following steps. In step 700, the method may includereceiving (or optionally 702 forming) a three-dimensional representationof a patient's teeth, gingiva, and/or palate of a patient's mouth. Asmentioned above, in some embodiments the anchors can be implanted beforeimaging, while in other embodiments, the anchors are implanted afterimaging. The anchors can be TADs, regular implants, or a combination ofthe two. In some variations the 3D digital model of the patient's upperarch (e.g., including palate, teeth and/or gingiva) may be received andmanipulated, including adding or calculating the positions of two ormore anchors. In some variations, the locations of two or morepre-implanted anchors within the patient's mouth, may be added to the 3Dmodel. For example, in step 704, the force that is applied to thepalate, anchors and/or teeth for separating the palate (and/oroptionally for moving the teeth in a desired direction and amount) maybe calculated from the 3D digital model. In addition, the force appliedto the anchors, teeth, and/or palate, or any sub-combination of thesefeatures, to expand the palate in a desired amount, may be calculated.In step 706, the reaction force that may be applied to one or morelocations on the anchors and/or palate, teeth and/or gingiva forbalancing the force applied to the one or more teeth may be calculated.In step 708, the shape for the orthodontic alignment device may bedetermined based on the model of the patient's teeth, palate, and/orgingiva, the calculated force that is applied to the teeth, and thecalculated reaction force that is applied to one or more locations onthe teeth, palate and/or gingiva, and/or anchors. In step 710, theorthodontic alignment device (e.g., palatal expander) may be fabricatedbased on the determined shape. Forces may be determined using acomputational model of the aligner based on FEA, for example, oraccording to the methods described in U.S. Pat. No. 9,375,300, which ishereby incorporated by reference in its entirety.

FIG. 8 is a flow chart that illustrates an example of acomputer-implemented method 800 for designing and/or fabricating aplurality of incremental palatal expanders. Implementations may includemore or less operations than those explicitly shown. The method 800 maybe executed by a computer processor and/or in conjunction withinstructions stored on computer memory.

At an operation 802, a plurality of representations of a palate of apatient at a plurality of stages of palatal expansion may be gathered inaccordance with a palatal expansion plan. The patient's dentition may becaptured through manual impressions and/or digitally scanned. Analogimpressions may themselves be scanned into a digital format. Thepatient's dentition may contain a representation of the patient's palatebefore undergoing treatment. Using orthodontic treatment and/or palatalexpansion software, various stages of palatal expansion may bedetermined. A “stage” of palatal expansion, as used herein, may includea state of a patient' palate during palatal expansion, and may include abeginning/initial stage before treatment, intermediate stages during thecourse of treatment, and an end/final stage after treatment. Stages ofpalatal expansion may correspond to different sizes of the palate as itexpands through a palatal expansion plan.

At an operation 804, a stage-specific plurality of anchor locations ineach of the plurality of representations of the palate for thecorresponding stage of palatal expansion may be identified. Thestage-specific plurality of anchor locations may be associated withlocations of a plurality of anchors to be inserted into a maxilla of thepatient at a corresponding stage of palatal expansion. As an example,pairs of anchors may be inserted into a patient's maxilla at the outsetof a treatment plan. The anchors in each pair may be substantiallyequidistant and/or symmetrically arranged about a patient's midline. Asthe patient's palate expands through the course of treatment, theanchors in each pair may separate from one another and/or the patient'smidline even though the anchors remain substantially stationary in thepatient's maxilla through the course of the treatment plan. In suchimplementations, the likely locations of anchor locations of the anchorswould be discerned for each stage of the palatal expansion plan. Suchlikely locations of the anchors at each stage of the palatal expansionmay be identified.

At an operation 806, a plurality of incremental palatal expanders forthe plurality of stages of palatal expansion may be virtuallyrepresented. Each of the incremental palatal expanders may provide anoutward, lateral force that causes the maxilla and/or palate to expand.Each of the incremental palatal expanders may provide an outward,lateral force that causes the patient to move from one stage of palatalexpansion to a subsequent stage of palatal expansion. Each of theincremental palatal expanders may have a palatal region that can matewith the patient's palate at the corresponding stage of palatalexpansion. The palatal region may include a rigid material that providesan outward, lateral forces. The plurality of incremental palatalexpanders may each have a plurality of stage-specific anchor interfacesat or approximately at the stage-specific plurality of anchor locations.The stage-specific anchor interfaces may be configured with a size,shape, and/or material that receives the plurality of anchors at thespecific stage of palatal expansion. As noted herein, the plurality ofstage-specific anchor interfaces may be configured to direct at least aportion of the outward, lateral force to the maxilla through theplurality of anchors. In various implementations, the stage-specificplurality of anchor locations comprise one or more pairs of anchorlocations, the anchor locations in each pair having a substantiallyequidistant distance from a midline of the palate. Additionally, invarious implementations, the substantially equidistant distance of theeach pair of anchor locations at an earlier stage of palatal expansionof the plurality of stages of palatal expansion may be smaller than thesubstantially equidistant distance of the each pair of anchor locationsat a later stage of palatal expansion of the plurality of stages ofpalatal expansion.

At an operation 808, instructions to directly fabricate the plurality ofincremental palatal expanders for the plurality of stages of palatalexpansion using the plurality of virtual representations of theplurality of incremental palatal expanders may be provided. At anoperation 810, the plurality of incremental palatal expanders for theplurality of stages of palatal expansion may be directly fabricatedusing the fabrication instructions.

Additional Considerations

When a feature or element is herein referred to as being “on” anotherfeature or element, it can be directly on the other feature or elementor intervening features and/or elements may also be present. Incontrast, when a feature or element is referred to as being “directlyon” another feature or element, there are no intervening features orelements present. It will also be understood that, when a feature orelement is referred to as being “connected”, “attached” or “coupled” toanother feature or element, it can be directly connected, attached orcoupled to the other feature or element or intervening features orelements may be present. In contrast, when a feature or element isreferred to as being “directly connected”, “directly attached” or“directly coupled” to another feature or element, there are nointervening features or elements present. Although described or shownwith respect to one embodiment, the features and elements so describedor shown can apply to other embodiments. It will also be appreciated bythose of skill in the art that references to a structure or feature thatis disposed “adjacent” another feature may have portions that overlap orunderlie the adjacent feature.

Terminology used herein is for the purpose of describing particularembodiments only and is not intended to be limiting of the invention.For example, as used herein, the singular forms “a”, “an” and “the” areintended to include the plural forms as well, unless the context clearlyindicates otherwise. It will be further understood that the terms“comprises” and/or “comprising,” when used in this specification,specify the presence of stated features, steps, operations, elements,and/or components, but do not preclude the presence or addition of oneor more other features, steps, operations, elements, components, and/orgroups thereof. As used herein, the term “and/or” includes any and allcombinations of one or more of the associated listed items and may beabbreviated as “/”. Gathering may include, for example, collecting,fabrication, ordering, receiving, sequencing, assembling, andorganizing.

Spatially relative terms, such as “under”, “below”, “lower”, “over”,“upper” and the like, may be used herein for ease of description todescribe one element or feature's relationship to another element(s) orfeature(s) as illustrated in the figures. It will be understood that thespatially relative terms are intended to encompass differentorientations of the device in use or operation in addition to theorientation depicted in the figures. For example, if a device in thefigures is inverted, elements described as “under” or “beneath” otherelements or features would then be oriented “over” the other elements orfeatures. Thus, the exemplary term “under” can encompass both anorientation of over and under. The device may be otherwise oriented(rotated 90 degrees or at other orientations) and the spatially relativedescriptors used herein interpreted accordingly. Similarly, the terms“upwardly”, “downwardly”, “vertical”, “horizontal” and the like are usedherein for the purpose of explanation only unless specifically indicatedotherwise.

Although the terms “first” and “second” may be used herein to describevarious features/elements (including steps), these features/elementsshould not be limited by these terms, unless the context indicatesotherwise. These terms may be used to distinguish one feature/elementfrom another feature/element. Thus, a first feature/element discussedbelow could be termed a second feature/element, and similarly, a secondfeature/element discussed below could be termed a first feature/elementwithout departing from the teachings of the present invention.

Throughout this specification and the claims which follow, unless thecontext requires otherwise, the word “comprise”, and variations such as“comprises” and “comprising” means various components can be co-jointlyemployed in the methods and articles (e.g., compositions and apparatusesincluding device and methods). For example, the term “comprising” willbe understood to imply the inclusion of any stated elements or steps butnot the exclusion of any other elements or steps.

As used herein in the specification and claims, including as used in theexamples and unless otherwise expressly specified, all numbers may beread as if prefaced by the word “about” or “approximately,” even if theterm does not expressly appear. The phrase “about” or “approximately”may be used when describing magnitude and/or position to indicate thatthe value and/or position described is within a reasonable expectedrange of values and/or positions. For example, a numeric value may havea value that is +/−0.1% of the stated value (or range of values), +/−1%of the stated value (or range of values), +/−2% of the stated value (orrange of values), +/−5% of the stated value (or range of values), +/−10%of the stated value (or range of values), etc. Any numerical valuesgiven herein should also be understood to include about or approximatelythat value, unless the context indicates otherwise. For example, if thevalue “10” is disclosed, then “about 10” is also disclosed. Anynumerical range recited herein is intended to include all sub-rangessubsumed therein. It is also understood that when a value is disclosedthat “less than or equal to” the value, “greater than or equal to thevalue” and possible ranges between values are also disclosed, asappropriately understood by the skilled artisan. For example, if thevalue “X” is disclosed the “less than or equal to X” as well as “greaterthan or equal to X” (e.g., where X is a numerical value) is alsodisclosed. It is also understood that the throughout the application,data is provided in a number of different formats, and that this data,represents endpoints and starting points, and ranges for any combinationof the data points. For example, if a particular data point “10” and aparticular data point “15” are disclosed, it is understood that greaterthan, greater than or equal to, less than, less than or equal to, andequal to 10 and 15 are considered disclosed as well as between 10 and15. It is also understood that each unit between two particular unitsare also disclosed. For example, if 10 and 15 are disclosed, then 11,12, 13, and 14 are also disclosed.

Although various illustrative embodiments are described above, any of anumber of changes may be made to various embodiments without departingfrom the scope of the invention as described by the claims. For example,the order in which various described method steps are performed mayoften be changed in alternative embodiments, and in other alternativeembodiments one or more method steps may be skipped altogether. Optionalfeatures of various device and system embodiments may be included insome embodiments and not in others. Therefore, the foregoing descriptionis provided primarily for exemplary purposes and should not beinterpreted to limit the scope of the invention as it is set forth inthe claims.

The examples and illustrations included herein show, by way ofillustration and not of limitation, specific embodiments in which thesubject matter may be practiced. As mentioned, other embodiments may beutilized and derived there from, such that structural and logicalsubstitutions and changes may be made without departing from the scopeof this disclosure. Such embodiments of the inventive subject matter maybe referred to herein individually or collectively by the term“invention” merely for convenience and without intending to voluntarilylimit the scope of this application to any single invention or inventiveconcept, if more than one is, in fact, disclosed. Thus, althoughspecific embodiments have been illustrated and described herein, anyarrangement calculated to achieve the same purpose may be substitutedfor the specific embodiments shown. This disclosure is intended to coverany and all adaptations or variations of various embodiments.Combinations of the above embodiments, and other embodiments notspecifically described herein, will be apparent to those of skill in theart upon reviewing the above description.

1. A system for expanding a patient's palate through a plurality ofincremental stages of palatal expansion, the system comprising: aplurality of palatal expanders, each palatal expander of the pluralityof palatal expanders configured to expand the patient's palatecomprising: a palatal region configured to mate with the patient'spalate at one incremental stage of the plurality of incremental stagesof palatal expansion, and to exert an outward, lateral force on thepatient's palate during the one incremental stage of palatal expansion;and at least two anchor interfaces, each anchor interface configured toreceive an anchor extending from a maxilla of the patient therein, andto direct at least a portion of the outward, lateral force to themaxilla through the anchors to facilitate skeletal expansion of themaxilla during the one incremental stage of palatal expansion.
 2. Thesystem of claim 1, wherein each of the at least two anchor interfaces ofeach palatal expander of the plurality of palatal expanders has anelastic interface therein, wherein the elastic interface has a greaterelasticity than the palatal region such that an anchor will displace theelastic interface more than the palatal region when the anchor isreceived in the anchor interfaces.
 3. The system of claim 2, wherein theelastic interface comprises a compressible material.
 4. The system ofclaim 3, wherein the compressible material has a thickness of betweenabout 0.2 mm to 1.5 mm.
 5. The system of claim 1, wherein: the palatalregion of each palatal expander of the plurality of palatal expandershas a first rigidity; and each palatal expander of the plurality ofpalatal expanders has a soft portion having a second rigidity less thanthe first rigidity, the second rigidity configured to grip and couplethe anchors to each palatal expander of the plurality of palatalexpanders.
 6. The system of claim 1, wherein the at least two anchorinterfaces are located on opposing lateral sides of the palatal region.7. The system of claim 1, wherein the at least two anchor interfaces areeach configured to receive a temporary anchorage devices.
 8. The systemof claim 1, wherein the at least two anchor interfaces of the eachpalatal expander of the plurality of palatal expanders are integrallyformed with each palatal expander of the plurality of palatal expanders.9. The system of claim 1, wherein the at least two anchor interfaces ofeach palatal expander of the plurality of palatal expanders comprise anopening at least partially through the palatal region.
 10. The system ofclaim 1, further comprising an anchor template having at least twoanchor guides for guiding implantation of the anchors into the maxilla,wherein the at least two anchor guides are positioned on the anchortemplate such that the anchors are inserted into the maxilla in anchorlocations that correspond to the anchor interfaces of the each palatalexpander of the plurality of palatal expanders.
 11. The system of claim1, wherein the each anchor interface has a sloped surface configured tofacilitate insertion of the anchor therein.
 12. The system of claim 1,wherein the each palatal expander of the plurality of palatal expanderscomprises at least four anchor interfaces.
 13. The system of claim 1,wherein the palatal region of each palatal expander of the plurality ofpalatal expanders is configured to be placed against the patient'spalate when the at least two anchor interfaces are each coupled withanchors.
 14. The system of claim 1, wherein at least a portion of thepalatal region of each palatal expander of the plurality of palatalexpanders is configured to be spaced apart from the patient's palatewhen the anchors are coupled with the anchor interfaces.
 15. The systemof claim 1, wherein the plurality of palatal expanders are fabricatedfrom a rigid or semi-elastic material.
 16. The system of claim 1,wherein each palatal expander of the plurality of palatal expanderscomprises a teeth region configured to be placed over a portion of thepatient's teeth.
 17. The system of claim 16, wherein the teeth region isconfigured to be placed over one or more of: a lingual surface of thepatient's teeth, an occlusal surface of the patient's teeth, and abuccal surface of the patient's teeth.
 18. A system for expanding apatient's palate, the system comprising: a series of palatal expanders,wherein each palatal expander comprises: a palatal region, wherein thepalatal region is sized and shaped to exert an outward, lateral forcethat expands the patient's palate; at least two anchor interfaceslocated on opposing lateral sides of the palatal region, the anchorinterfaces configured to receive anchors implanted in the patient'smaxilla such that the outward, lateral force exerted by the palatalregion are transmitted through the anchors to the patient's maxilla; andwherein each of the anchor interfaces has an elastic interface therein,wherein the elastic interface has a greater elasticity than the palatalregion such that an anchor will displace the elastic interface more thanthe palatal region when the anchor is received in the anchor interfaces.19. A system for expanding a patient's palate through a plurality ofincremental stages of palatal expansion, the system comprising: aplurality of palatal expanders, each palatal expander of the pluralityof palatal expanders comprising: a palatal region configured to matewith the patient's palate at one incremental stage of the plurality ofincremental stages of palatal expansion, and to exert an outward,lateral force on the palate during the one incremental stage of palatalexpansion; and a means for receiving a plurality of anchors that areinserted in a maxilla of the patient, and to direct at least a portionof the outward, lateral force to the maxilla through the plurality ofanchors to expand the maxilla during the one incremental stage ofpalatal expansion. 20-35. (canceled)